Anastomotic coupler

ABSTRACT

An anastomotic coupler is provided. A ring can include a receiving portion. A fixation device includes a cartridge. The cartridge includes a plurality of fasteners. Upon actuation of the fixation device, the fasteners puncture the tubular structure. The fasteners are received by the receiving portions such that the tubular structure is coupled with the ring.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part application of U.S.application Ser. No. 17/932,027 filed Sep. 14, 2022, which is acontinuation-in-part application of U.S. application Ser. No. 17/536,439filed Nov. 29, 2021, which is a continuation-in-part application of U.S.application Ser. No. 17/365,484 filed Jul. 1, 2021, which is acontinuation-in-part application of U.S. application No. 17/181,440filed Feb. 22, 2021, which is a continuation application of U.S.application Ser. No. 16/950,209 filed Nov. 17, 2020, now U.S. Pat. No.10,939,913, which claims the benefit of U.S. Provisional PatentApplication No. 62/936,868, filed in the U.S. Patent and TrademarkOffice on Nov. 18, 2019, and U.S. Provisional Patent Application No.63/061,303, filed in the U.S. Patent and Trademark Office on Aug. 5,2020, each of which is incorporated herein by reference in its entiretyfor all purposes.

FIELD

The present disclosure relates generally to an anastomotic coupler. Inat least one example, the present disclosure relates to a surgicalsystem and method to utilize an anastomotic coupler to connect twotubular structures such as vessels, esophagus, intestine, lymphaticstructure, and/or graft material.

BACKGROUND

An anastomosis is a connection between two luminal structures. Commonly,these connections can occur with blood vessels (for example, vascularanastomosis), or tubular gastrointestinal structures (for example,intestines, stomach, esophagus). Conventional techniques allow theanastomosis to be completed between two ends (referred to as end-to-endanastomosis), or between the end of one structure and the side ofanother structure (referred to as end-to-side anastomosis). Proceduresrequiring these anastomoses are carried out thousands of times per day,globally. Likewise, multiple surgical specialties rely upon the creationof reliable, unobstructed anastomoses for successful treatment of theirrespective patients.

BRIEF DESCRIPTION OF THE DRAWINGS

Implementations of the present technology will now be described, by wayof example only, with reference to the attached figures, wherein:

FIG. 1 illustrates a diagram of an anastomotic coupler;

FIG. 2 illustrates a fixation device;

FIG. 3 illustrates a tubular structure being received by a fixationdevice;

FIG. 4 illustrates a ring being aligned with a cartridge of the fixationdevice;

FIG. 5 illustrates a cross-sectional view of FIG. 4 ;

FIG. 6 illustrates an exemplary fastener;

FIG. 7 illustrates another example of a fastener;

FIG. 8 illustrates another example of a fastener;

FIG. 9 illustrates a cross-sectional view of the cartridge aligned withthe ring;

FIG. 10A illustrates actuation of the fixation device;

FIG. 10B illustrates a cross-sectional view of FIG. 10A;

FIG. 11 illustrates an exemplary ring;

FIG. 12 illustrates an example of another ring;

FIG. 13 illustrates a cross-sectional view of two rings coupled with oneanother to join two tubular structures;

FIG. 14 illustrates a cap disposed over the two rings of FIG. 13 ;

FIG. 15 illustrates an exemplary cap;

FIG. 16 is a flow chart of a method for utilizing an anastomoticcoupler;

FIG. 17A illustrates a fixation device engaging with a side hole of atubular structure;

FIG. 17B illustrates a ring being aligned on the tubular structure ofFIG. 17A;

FIG. 17C illustrates actuation of the fixation device;

FIG. 17D illustrates the ring being coupled with the side of the tubularstructure;

FIG. 17E illustrates a second tubular structure being coupled with thetubular structure;

FIG. 18 is a flow chart of a method for coupling an end of a tubularstructure with a side of a tubular structure;

FIG. 19 illustrates an exemplary cartridge;

FIG. 20 illustrates the cartridge of FIG. 19 with a sheath covering thefasteners;

FIGS. 21A, 21B, and 21C illustrate actuation of a fixation device;

FIGS. 22A, 22B, and 22C illustrate coupling two tubular structures withan exemplary cartridge;

FIGS. 23A, 23B, and 23C illustrate coupling two tubular structures withan exemplary cartridge;

FIGS. 24A, 24B, and 24C illustrate coupling two tubular structures withan exemplary cartridge;

FIGS. 25A, 25B, and 25C illustrate coupling two tubular structures withan exemplary cartridge;

FIGS. 26A and 26B illustrate exemplary cartridges;

FIGS. 27A-L illustrate deployment of the cartridge;

FIG. 27M illustrates coupling of the cartridge with a ring;

FIG. 27N illustrates coupling two tubular structures with the cartridgesand rings;

FIG. 28 illustrates an exemplary cartridge;

FIGS. 29A, 29B, and 29C illustrate the cartridge with the arms extendedat an angle;

FIG. 30 illustrates the cartridge with the bevel with the arms extendedat an angle;

FIGS. 31A and 31B illustrate the cartridge coupling a male ring with atubular structure;

FIG. 31C illustrates the male ring;

FIGS. 32A illustrates the cartridge coupling a female ring with atubular structure;

FIG. 32B illustrates the female ring; and

FIG. 33 illustrates the male ring coupled with the female ring to couplethe two tubular structures together.

DETAILED DESCRIPTION

It will be appreciated that for simplicity and clarity of illustration,where appropriate, reference numerals have been repeated among thedifferent figures to indicate corresponding or analogous elements. Inaddition, numerous specific details are set forth in order to provide athorough understanding of the examples described herein. However, itwill be understood by those of ordinary skill in the art that theexamples described herein can be practiced without these specificdetails. In other instances, methods, procedures and components have notbeen described in detail so as not to obscure the related relevantfeature being described. Also, the description is not to be consideredas limiting the scope of the examples described herein. The drawings arenot necessarily to scale and the proportions of certain parts may beexaggerated to better illustrate details and features of the presentdisclosure.

The original technique for vascular suture anastomoses was created byAlexis Carrel between 1901-1910. This pioneering work resulted in Carrelreceiving the Nobel Prize in 1912. Despite 100 years of surgicalevolution and innovation since that discovery, the majority of vascularanastomoses to this day still employ suture techniques similar toCarrel's initial description in the early 1900s. In the 1970s,gastrointestinal stapling devices were introduced, which quicklyreplaced primary suture techniques for bowel anastomoses. However, mostsurgeons still employ circumferential suture techniques in the serosallayer overlying the stapled anastomosis for added support. Althoughgenerally successful, these techniques can take long periods of time,often require additional surgical expertise, and if not performedcorrectly, may result in leakage (blood, stool contents, gastriccontents, lymphatic fluid), constriction, stenosis, and/or obstructionat the anastomotic site. In the case of vascular anastomoses, stenosisand/or obstruction can result in catastrophic complications such asheart attack, stroke, peripheral limb ischemia, amputation, death, andreconstructive failure and soft-tissue loss. For example, in the settingof gastrointestinal anastomoses, these complications can result inextra-luminal leak of gastrointestinal contents, infection, sepsis,obstruction, and death.

With the understood importance of reliable, open anastomoses,alternatives to sutures and staples have been used. An example of avascular anastomotic coupler is described, for instance, in U.S. PatentPub. No. 2015/0088172 A1 (the '172 Publication). This coupler has twocircular ends with spikes or pins. The vessel is brought through thering and the vessel wall is everted, or rolled over, the pins forsecurement as shown in FIGS. 2A and 2B of the '172 Publication. This iscompleted on each vessel end, and the two rings are then broughttogether with the spikes/pins being forced into the opposite ring tojoin the ends together as shown in FIG. 1C of the '172 Publication.However, because of the potential for micro-motion of the vessels andsize mismatch due to the anastomotic coupler of the '172 Publication,blood leakage may happen, and/or one of the pins may tear through thevessel wall creating a leak and/or site for platelet aggregation andthrombosis (blood clot formation). Likewise, with the anastomoticcoupler of the '172 Publication, for thicker walled, less elasticvessels, particularly arteries, everting vessel edges can be quitedifficult and may result in trauma to the vessel wall (intima) and/orstenosis at the anastomosis, both of which can create plateletaggregation, turbid flow, and/or thrombosis with subsequent obstructionof flow. Additionally, the technique of the '172 Publication requiresadditional specialized equipment (surgical microscope, high-poweredloupe magnification) to use. For gastrointestinal stapled anastomoses,many procedures are performed either side-to-side which is not a naturalpathway for intestinal smooth muscle propulsion of stool contents (forexample, non-longitudinal flow along the length of the intestine), orend-to-end, which requires a separate, remote full-thickness bowelaccess incision for deployment, thereby creating a secondary weak pointfor potential leak, or adhesion formation.

Referring now to FIG. 1 , an anastomotic coupler 10 is provided. Theanastomotic coupler 10 is provided to create a connection betweenadjacent tubular structures 12. The tubular structure 12 can includeblood vessels, grafts, prostheses, gastrointestinal structures,esophagus, lymphatics, and/or any other suitable channels of the body orthe operation for which the tubular structure 12 is created. The tubularstructure 12 forms a lumen 14 through which matter can be passed, forexample blood, food, fluids, and/or cells.

The anastomotic coupler 10 includes a ring 300 forming an aperture 302.The ring 300 is operable to receive a tubular structure 12 through theaperture 302. While the ring 300 as illustrated in FIG. 1 has asubstantially circular shape, the ring 300 can have any suitable shapesuch as rectangular, triangular, octagonal, hexagonal, and/or oval.Additionally, the ring 300 as illustrated in FIG. 1 is a singular solidpiece, in some examples, for ease of application or manufacturingpurposes, the ring 300 can include two semi-circular or arc-type piecesthat are joined together around the tubular structure 12.

The size of the lumen 302 of the ring 300 can vary based on theapplication and the size of the tubular structure 12. For example, thediameter of the lumen 302 can range from about 0.5 millimeters (mm) (forexample for lymphatic connections) to about 60 millimeters (for examplefor gastrointestinal connections). Due to the range of diameters for thering 300, and the range of diameters for the tubular structure 12, theappropriate ring 300 can be selected by measuring the internal diameterof the tubular structure 12. This can be accomplished, for example, withan intraluminal measurement guide/device. If there is a significant sizemismatch (1 mm or greater) between the tubular structure 12 and the ring300, then a short, cylindrical tube connector with a corresponding maleand female end can be used to allow for gradual transition in size inany direction to accommodate the size difference. For example, acylindric tube can be provided that tapers in size such that one end is1 mm-2 mm larger/smaller than the other end, which would enable aconnection of a 1 mm vessel to a 2.5 mm-3.5 mm vessel duringmicrosurgical procedures without problem and vice versa.

Referring also to FIG. 2 , the anastomotic coupler 10 also includes afixation device 100. The fixation device 100 is operable to couple thetubular structure 12 with the ring 300. The fixation device 100 caninclude a housing 102 and a cartridge 200. The cartridge 200 includes aplurality of fasteners 206 (as shown in FIGS. 5-10B). The fasteners 206are operable to puncture the tubular structure 12 and be partiallyreceived in the ring 300 to couple the tubular structure 12 with thering 300. In at least one example, the cartridge 200 can be removablycoupled with the housing 102. Accordingly, the cartridge 200 may bereplaceable to allow multiple uses of the fixation device 100. In someexamples, the cartridge 200 may not be removable such that the fixationdevice 100 is provided for a one-time use. The fixation device 100 caninclude a pusher rod 150 operable to actuate the fixation device 100 todrive the fasteners 206 from the cartridge 200. Upon actuation of thefixation device 100, the pusher rod 150 can translate along alongitudinal axis.

The fixation device 100 includes stop 104 to receive the tubularstructure 12. In at least one example, the stop 104 can be formed as aportion of the cartridge 200 to ensure alignment with the cartridge 200.In some examples, the stop 104 can be formed as a portion of the housing102. The stop 104 extends radially from the housing 104 such that a freeend of the tubular structure abuts the stop 104. As illustrated in FIG.3 , the housing 102 receives the free end of the tubular structure 12such that the cartridge 200 is inserted into the lumen 14 of the tubularstructure. When correctly positioned, the free end of the tubularstructure 12 abuts the stop 104. The stop 104 ensures the placement andalignment of the ring 300, the cartridge 200, and the free end of thetubular structure 12. The alignment of the ring 300, the cartridge 200,and the free end of the tubular structure 12 is critical to ensureadequate connection between the tubular structure 12 and another tubularstructure 12.

As illustrated in FIG. 4 , after the tubular structure 12 is received bythe fixation device 100 and abuts the stop 104, the ring 300 can bepositioned to abut the stop such that the ring 300 is aligned with thefree end of the tubular structure 12.

The stop 104 can include a plurality of alignment components 106 whichcorrespond with alignment components 304 of the ring 300. Accordingly,when the ring 300 is aligned and/or correctly positioned, the alignmentcomponents 106 of the stop 104 are aligned with the alignment components304 of the ring 300. In some examples, the alignment components 106, 304can include one or more alignment markers 108, 304. The alignmentmarkers 108, 304 can be shaped, for example as triangles. Accordingly,to align the ring 300, the tips of the triangles for the alignmentmarkers 108, 304 can point towards one another. In some examples, thealignment components 106, 304 can include one or more alignment pins 110and corresponding alignment receivers 308. When the ring 300 is aligned,the alignment pins 100 can be received by the alignment receivers 308.While the figures illustrate the alignment pins 100 being disposed onthe fixation device 100 and the alignment receivers 308 being disposedon the ring 300, in some examples, the alignment pins 100 may bedisposed on the ring 300 and the alignment receivers can be disposed onthe fixation device 100.

FIG. 5 illustrates a cross-sectional view of the tubular structure 12,the ring 300, and the cartridge 200 aligned. In addition to ensuring thering 300 aligns with the free end of the tubular structure 12, the ring300 is aligned with the cartridge 200. When the ring 300 is properlyaligned with the cartridge 200, a plurality of receiving portions 310 ofthe ring 300 are aligned with the plurality of fasteners 206 of thecartridge 200.

The fasteners 206 can be any suitable fastener 206 to couple the ring300 with the tubular structure 12 and prevent movement between the ring300 and the tubular structure 12. For example, the fasteners 206 caninclude tacks 600, 700 (as shown in FIGS. 6 and 7 ), staples 800 (asshown in FIG. 8 ), pins, adhesive, internal ring, internal mesh, wire,clamp, coil, stent, and/or suture.

As illustrated in FIG. 6 , the tack 600 can include a puncturing portion602 which is operable to puncture the tubular structure 12. An abutmentsurface 603 abuts against a surface of the corresponding receivingportion 310 of the ring 300. A body 604 spans the thickness of the wallof the tubular structure 12, and an end 606 includes an abutment surface608 which abuts against the inner surface of the tubular structure 12.The abutment surfaces 603, 608 prevent the fastener 206 from beingremoved from the tubular structure 12 and the ring 300.

As illustrated in FIG. 7 , the tack 700 can include a puncturing portion702 which is operable to puncture the tubular structure 12. Theexemplary tack 700 does not include as long of a puncturing portion 702as the puncturing portion 602 as illustrated in FIG. 6 . An abutmentsurface 703 abuts against a surface of the corresponding receivingportion 310 of the ring 300. A body 704 spans the thickness of the wallof the tubular structure 12, and an end 706 includes an abutment surface708 which abuts against the inner surface of the tubular structure 12.The abutment surfaces 703, 708 prevent the fastener 206 from beingremoved from the tubular structure 12 and the ring 300.

As illustrated in FIG. 8 , the staple 800 can include two puncturingportions 802 which are operable to puncture through the tubularstructure 12 and be received in the corresponding receiving portion 310of the ring 300. A body 804 spans between the puncturing portions 802and is operable to abut the inner surface of the tubular structure 12 toprevent the fastener 206 from being removed from the tubular structure12. In at least one example, the puncturing portions 802 may be operableto bend or deform when received in the receiving portion 310 to preventthe puncturing portions 802 from being removed from the ring 300,ensuring coupling of the tubular structure 12 with the ring 300.

Referring to FIGS. 5 and 9 , the cartridge 200 can include a pluralityof drivers 204 corresponding with the plurality of fasteners 206. Uponactuation of the fixation device 100, the drivers 204 activate to pushthe corresponding fasteners 206 radially outward from the cartridge 200.The drivers 204 may include rods which abut the fasteners 206 andtowards the center of the body 202 of the cartridge 200. In someexamples, the drivers 204 may be spring loaded.

The pusher rod 150, as illustrated in FIG. 5 , is tapered from a frontportion 154 with a smaller diameter D1 to a rear portion 152 with alarger diameter D2 which is greater than the smaller diameter D1. Thedrivers 204 may abut the fasteners 206 on one end while extending intothe cartridge 200 so that the opposing end of the fasteners 206 abut thepusher rod 150.

Referring to FIGS. 10A and 10B, the fixation device 100 is actuated.Actuation of the fixation device 100 can include translating the pusherrod 150 along the longitudinal axis through the cartridge 200 from thefront portion 154 towards the rear portion 152. The pusher rod 150,increasing in thickness, then activates the drivers 204 to drive thefasteners 206 radially outward from the cartridge 200, through thetubular structure 12, and into the receiving portions 310 of the ring300. Once the ring 300 is coupled with the tubular structure 12, thefixation device 100 can be removed from the tubular structure 12. Thering 300 is then affixed or secured to the end of the tubular structure12, maintaining the structure of the lumen of the tubular structure 12.

The fixation device 100, the ring 300, and/or the fasteners 206 can bemade from mechanically suitable materials that are approved, and havesufficient strength, for use in the human or animal body. For example,the following materials, alone or in any combination, can be used:metals, in particular titanium or stainless steel, including the specialalloys used for implants and medical instruments, nitinol, carbonmaterials, including carbon fiber meshes, soft plastic, for examplesilicone, hard plastic, for example Teflon, ceramic material, and/orbioresorbable material. The fixation device 100, the ring 300, and/orthe fasteners 206 can be provided entirely or partially with a coatingand/or structure that prevents or at least reduces the adherence ofblood constituents. Such a coating can be composed of a material thatsmooths the surface. In at least one example, the coating can alsocontain anti-thrombotic medicaments (e.g. heparin).

The above process of coupling the ring 300 with the tubular structure 12can be repeated for a second tubular structure 12 with a second ring300. For example, FIG. 11 illustrates an exemplary male ring 350, andFIG. 12 illustrates an exemplary corresponding female ring 350. Similarto the ring 300 discussed above, the male ring 350 and the female ring360 each include an aperture 302 operable to receive a tubular structure12, receiving portions 310 operable to receive the fasteners 206, andalignment portions 304, 308. The male ring 350 includes a mating portion352, and the female ring 360 includes a corresponding mating portion362. The mating portion 352 is operable to couple with the matingportion 362 to couple the male ring 350 and the female ring 360 with oneanother. As illustrated in FIGS. 11 and 12 , the mating portion 352 ofthe male ring 350 extends from the ring 350 and is operable to bereceived by the mating portion 362 of the female ring 360. In someexamples, the rings 300 can be coupled with one another by, for example,fastening, snapping, clamping, stenting, tacking, pinning, loop andhook, adhesive, and/or other connecting method so long as the rings 300are securely coupled with one another.

As illustrated in FIG. 13 , when the rings 350, 360 are coupled with oneanother, the lumens 14 of the two tubular structures 20, 22 are alignedin fluid communication with one another. In at least one example, therings 350, 360 can create a seal to prevent fluid leakage. Accordingly,the anastomotic coupler 10 provides a more reliable, faster, more secureanastomotic coupling device to create a sealed, leak-proof, openconnection between the ends of the tubular structures 20, 22 and allowfor “stented” unobstructed flow of luminal contents through theconnection/anastomosis (e.g. blood, lymph, fluid, stool contents,gastric contents, etc.). This connection can be strong enough towithstand tension, traction, and high flow pressure, which may occurwith distal obstruction.

As illustrated in FIG. 14 , a cap 1400 can be provided over the tworings 350, 360. The cap 1400 can assist in ensuring the connectionbetween the rings 350, 360, as well as protecting the rings 350, 360from external damage. As illustrated in FIG. 15 , the cap 1400 caninclude a recess 1402 which is operable to receive the two rings 350,360. An opening 1404 can be formed such that the cap 1400 can bedeformed to snap over the two rings 350, 360.

Referring to FIG. 16 , a flowchart is presented in accordance with anexample embodiment. The method 1600 is provided by way of example, asthere are a variety of ways to carry out the method. The method 1600described below can be carried out using the configurations illustratedin FIG. 1-15 , for example, and various elements of these figures arereferenced in explaining example method 1600. Each block shown in FIG.16 represents one or more processes, methods or subroutines, carried outin the example method 600. Furthermore, the illustrated order of blocksis illustrative only and the order of the blocks can change according tothe present disclosure. Additional blocks may be added or fewer blocksmay be utilized, without departing from this disclosure. The examplemethod 1600 can begin at block 1602.

At block 1602, a first tubular structure is received in an aperture of afirst ring.

At block 1604, a fixation device receives the first tubular structuresuch that a first cartridge is inserted into a lumen of the firsttubular structure.

At block 1606, the first ring is aligned with the first cartridge suchthat a plurality of receiving portions of the first ring are alignedwith a plurality of fasteners of the first cartridge.

At block 1608, the fixation device is actuated such that the pluralityof fasteners puncture the first tubular structure radially outward fromthe lumen. The cartridge can include a plurality of driverscorresponding with the plurality of fasteners. Upon actuation of thefixation device, the drivers activate to push the correspondingfasteners radially outward from the cartridge. In at least one example,the fixation device can include a pusher rod. The pusher rod can betapered from a front portion with a smaller diameter to rear portionwith a larger diameter. Upon actuation of the fixation device, thepusher rod can translate along a longitudinal axis to activate thedrivers. In at least one example, to activate the drivers, the pusherrod translates along the longitudinal axis and passes through thecartridge from the front portion to the rear portion such that thepusher rod abuts and pushes the drivers and the corresponding fastenersradially outward from the cartridge.

At block 1610, the first tubular structure is coupled with the firstring by the receiving portions receiving the plurality of fasteners.

In at least one example, a second tubular structure can be received inan aperture of a second ring. A fixation device can receive the secondtubular structure such that a second cartridge is inserted into a lumenof the second tubular structure. In at least one example, the fixationdevice may be the same fixation device that was utilized for the firstring. In some examples, the fixation device may be the same fixationdevice utilized for the first ring with a second cartridge that replacedthe first cartridge. In some examples, the fixation device may be asecond fixation device. The second ring can be aligned with the secondcartridge such that a plurality of receiving portions of the second ringare aligned with a plurality of fasteners of the second cartridge. Thefixation device can be actuated such that the plurality of fastenerspuncture the second tubular structure radially outward from the lumen.The second tubular structure can be coupled with the second ring by thereceiving portions receiving the plurality of fasteners.

The first ring can be aligned with the second ring such that the lumenof the first tubular structure and the lumen of the second tubularstructure are aligned in fluid communication with one another. The firstring can be coupled with the second ring to join the first tubularstructure with the second tubular structure, providing a continuouspassage between the first tubular structure and the second tubularstructure. In at least one example, a cap can be positioned about thefirst and the second ring to ensure the connection between the firstring and the second ring.

FIGS. 17A-17E illustrate examples of an anastomotic coupler 10 which isoperable to couple an end of a tubular structure 12 with a side of atubular structure 12. Elements described in the system of FIGS. 17A-18that have similar or the same name and/or the same reference numbers aselements in the disclosure for FIGS. 1-16 may have the same features asdiscussed above. While the discussion below for FIGS. 17A-17E mayhighlight some differences in features, the disclosure for the system ofFIGS. 17A-18 are not limited to those and may also include any and/orall of the features as discussed above.

FIG. 17A illustrates alignment and positioning of a fixation device 100and a ring 300 on a tubular structure 12. The fixation device 100 andthe ring 300 are positioned such that the ring 300 can be coupled to thetubular structure 12 where an aperture 302 of the ring 300 can bealigned with a hole 1300 formed in a wall 13 of the tubular structure12. In other words, the tubular structure 12 has a hole 1300 formed in aside wall 13. In at least one example, a cutting mechanism (not shown)can be operable to cut the hole 1300 in the wall 13 of the tubularstructure 12. In some examples, the cutting mechanism can be a separatecomponent operable to cut a precise hole 1300 in the wall 13 of thetubular structure 12. In some examples, the cutting mechanism can bepart of the fixation device 1700 such that only one component is neededin the fixation device 1700 to cut a hole 1300 and couple the ring 300to the tubular structure 12. The cutting mechanism can create asymmetrical, controllable-sized opening in the side wall 13 of thetubular structure 12.

In at least one example, the fixation device 1700 can be similar tofixation device 100 as discussed herein. In some examples, fixationdevice 1700 may be modified to couple the ring 1702 to the wall 13 ofthe tubular structure 12 to align with the hole 1300 in the wall 13instead of coupling the ring 1702 to the tubular structure 12 in linewith the lumen 14 of the tubular structure. In at least one example, thefixation device 1700 can include a stop which extends radially from thehousing 102 such that the wall 13 of the tubular structure 12 abuts thestop. Accordingly, the fixation device 1700 provides guidance to theuser for when the fixation device 1700 is in a desired position. In someexamples, the stop can include a plurality of alignment componentscorresponding with alignment components of the ring 1702. As such, whenthe ring 1702 is aligned, the alignment components of the stop arealigned with the alignment components of the ring 1702.

As illustrated in FIGS. 17A and 17B, a cartridge 1710 can be disposedwithin the lumen 14 of the tubular structure 12. The cartridge 1710,similar to cartridge 300, includes a plurality of fasteners 260 (forexample shown in 17C-17E) operable to be received in correspondingplurality of receiving portions 310 in the ring 300. The ring 1702, asillustrated in FIGS. 17A-17E has a cylindrical shape. However, in otherexamples, the ring 1702 can have any suitable shape such that the ring1702 can be aligned with the hole 1300 and prevent leakage between thetubular structure 12 and the ring 1702. The ring 1702, in some examples,may include a sealing component operable to abut against the wall 13 ofthe tubular structure 12 to prevent leakage of fluid.

In some examples, the position of the receiving portions 310 in the ring1702 may be adjusted to better receive the plurality of fasteners 260and provide a stronger coupling between the ring 1702 and the tubularstructure 12. For example, as illustrated in FIGS. 17A-17E, thereceiving portions 310 may be disposed towards the bottom of the ring1702 so that the receiving portions 310 are adjacent to the tubularstructure 12.

Similarly, in some examples, the position of the fasteners 260 in thecartridge 1710 may be adjusted towards the top to be adjacent to thewall 13 of the tubular structure 12. Accordingly, the distance betweenthe fasteners 260 in the cartridge 1710 and the receiving portions 310can be smaller to minimize the chance of error in coupling the ring 1702with the tubular structure 12.

As illustrated in FIG. 17A-17C, the ring 1702 can be positioned oppositethe cartridge 1710 in relation to the wall 13 of the tubular structure12. The ring 1702 can be positioned external of the tubular structure 12so that the ring 1702 does not cause any obstruction in the lumen 14 ofthe tubular structure 12. The cartridge 1710, as illustrated in FIGS.17A-17C, can be positioned inside the lumen 14 of the tubular structure12 to push the fasteners 260 across the wall 13 of the tubular structure12 into the receiving portions 310 of the ring 1702. In some examples,the cartridge 1710 may also be positioned external of the tubularstructure 12, so long as the fasteners 260 can couple the ring 1702 withthe tubular structure 12.

As illustrated in FIGS. 17C, the fixation device 1700 can be actuated sothat the plurality of fasteners 260 puncture the tubular structure 12and are received by the receiving portions 310. Accordingly, the tubularstructure 12 can be coupled with the ring 1702. In at least one example,as illustrated in FIG. 17C, the fixation device 1700 can include apusher rod 150. Upon actuation of the fixation device 1700, the pusherrod 150 can translate along a longitudinal axis to activate drivers topush the corresponding fasteners 260 from the cartridge 1710. In someexamples, the fixation device 1700 can have any suitable mechanism toactivate the drivers to push the fasteners 260 from the cartridge 1710.

As illustrated in FIG. 17D, after the ring 1702 is coupled with thetubular structure 12, the fixation device 1700, along with the cartridge1710, can be removed. The ring 1702 remains coupled with the tubularstructure 12 such that the aperture 302 of the ring 1702 is aligned withthe hole 1300 in the wall 13 of the tubular structure 12.

As illustrated in FIG. 17E, the ring 1702 is operable to be coupled witha second tubular structure 22 such that a lumen 14 of the second tubularstructure 22 is in fluid communication with the lumen 14 of the tubularstructure 20 via the hole 1300 formed in the wall 13 of the tubularstructure 20. The side ring 1702 is operable to be coupled with thefirst tubular structure 20 such that the aperture 302 of the side ring1702 is aligned with the hole 1300 formed in the wall 13 of the firsttubular structure 12. The end ring 1704, similar to the rings 350, 360as illustrated in FIGS. 1-14 , is operable to be coupled with a secondtubular structure 22 such that the aperture 302 of the end ring 1704 isin line with the lumen 14 of the second tubular structure 22. The sidering 1702 is operable to be coupled with the end ring 1704 such that thelumen 14 of the second tubular structure 22 is in fluid communicationwith the lumen 14 of the first tubular structure 20 via the hole 1300formed in the wall 13 of the first tubular structure 20. Accordingly, anend-to-side anastomosis is achieved. In some examples, the side ring1702 and the end ring 1704 create a seal to prevent fluid leakage. Theseal can be achieved by any suitable mechanism.

As illustrated in FIG. 17E, fluid may flow through the lumen 14 of thefirst tubular structure 20 while some fluid may flow into and throughthe lumen 14 of the second tubular structure 22. In some examples, fluidfrom the second tubular structure 22 may flow into the first tubularstructure 20.

The aforementioned side-to-end anastomotic coupler 50 and systemprovides users with a better, more reliable alternative to theconventional techniques. The only technique conventionally practiced forside-to-end anastomosis is through hand-sewn suture techniques.Hand-sewn suture techniques are labor intensive and prone to failure.Similarly, the process of creating the side opening in the tubularstructure is conventionally completed in an uncontrolled fashion using ascalpel or scissors to haphazardly cut the side of the structure, whichcan result in an asymmetric opening of variable size.

Referring to FIG. 18 , a flowchart is presented in accordance with anexample embodiment. The method 1800 is provided by way of example, asthere are a variety of ways to carry out the method. The method 1800described below can be carried out using the configurations illustratedin FIG. 1-17E, for example, and various elements of these figures arereferenced in explaining example method 1800. Each block shown in FIG.18 represents one or more processes, methods or subroutines, carried outin the example method 1800. Furthermore, the illustrated order of blocksis illustrative only and the order of the blocks can change according tothe present disclosure. Additional blocks may be added or fewer blocksmay be utilized, without departing from this disclosure. The examplemethod 1800 can begin at block 1802.

At block 1802, a side ring is coupled with a first tubular structuresuch that an aperture of the side ring is aligned with a hole formed ina wall of the first tubular structure.

At block 1804, the side ring is coupled with a second tubular structuresuch that a lumen of the second tubular structure is in fluidcommunication with a lumen of the first tubular structure via the holeformed in the wall of the first tubular structure. In at least oneexample, the second tubular structure can be coupled with an end ringsuch that an aperture of the end ring is in line with the lumen of thesecond tubular structure. The side ring can be coupled with the end ringto join the first tubular structure with the second tubular structure.In at least one example, the side ring and the end ring can create aseal to prevent fluid leakage.

FIGS. 19-25C illustrate examples of an anastomotic coupler 10 which isoperable to couple two tubular structures 12 with a cartridge 200 havingfasteners 206 extending therefrom at an angle 1902A. Elements describedin the system of FIGS. 19-25C that have similar or the same name and/orthe same reference numbers as elements in the disclosure for FIGS. 1-18may have the same features and/or functions as discussed above. Whilethe discussion below for FIGS. 19-25C may highlight some differences infeatures, the disclosure for the system of FIGS. 19-25C are not limitedto those and may also include any and/or all of the features asdiscussed above. Similarly, the examples in FIGS. 1-18 may utilize anyand/or all of the features as discussed below for FIGS. 19-25C.

FIG. 19 illustrates an exemplary cartridge 200, 1900 which includes abody 1901 and fasteners 206, 1902 extending from the body 1901. The body1901, as illustrated in FIG. 19 , can be substantially cylindrical. Inother examples, the body 1901 can be in other configurations or shapessuch as rectangular, ovoid, or any other suitable shape. In someexamples, the body 1901 can include mesh, braided mesh, stent, and maybe a solid ring and/or tube, and/or any combination of mesh, stent, andsolid material. The body 1901 can form a lumen 1903 which passes throughthe body 1901. The lumen 1903 is operable to permit fluidic passageacross the body 1901 through the lumen 1903. Accordingly, when thecartridge 1900 is disposed within the tubular structure(s) 12, the lumen1903 is in fluid communication with the lumen 14 of the tubularstructure(s) 12 such that fluid can pass through the lumen 1903 betweenthe tubular structure(s) 12.

The fasteners 1902 extend from the body 1901 of the cartridge 1900 at anangle 1902A from the body 1901. For example, the fasteners 1902 mayextend at an angle 1902A that is between about 1 degree and about 89degrees. The fasteners 1902 may extend at an angle 1902 that is greaterthan 0 degrees and less than 90 degrees. In such an example, thefasteners 1902 may be deployed by rotating the fasteners 1902 inrelation to the tubular structure 12. In some examples, the fasteners1902 may extend at an angle 1902A of 90 degrees (directly radiallyoutward similar to FIGS. 1-18 ), and may be actuated by expansion of thebody 1901 of the cartridge 200. The fasteners 1902 are operable topuncture through a wall of one and/or two tubular structure(s) 12. Insome examples, the fasteners 1902 can have a hook design.

In at least one example, as illustrated in FIG. 19 , the fasteners 1902can be coupled to the body 1901 of the cartridge 1900. In some examples,as illustrated in FIGS. 22A-25C, the fasteners 1902 can be formed as apart of the body 1901 such that the fasteners 1902 and the body 1901 areone unitary piece and/or material.

FIG. 20 illustrates a sheath 2000 operable to cover the fasteners 1902.Accordingly, upon insertion of the cartridge 1900 into the tubularstructure 12, the fasteners 1902 are not inadvertently scratching and/orpuncturing the tubular structure 12

As the fasteners 1902 extend at an angle 1902A from the body 1901, thefasteners 1902 are operable to puncture through the tubular structure 12when the cartridge 1900 is rotated about a longitudinal axis in relationto the tubular structure 12. Due to the fasteners 1902 puncturing thetubular structure 12 at an angle, the fasteners 1902 couple thecartridge 1900 with the tubular structure 12 so that the fasteners 1902are not easily removed. For example, the tubular structure 12 or thecartridge 1900 would have to move relative to one another at aspecification rotation and distance from one another to de-couple thefasteners 1902 from the tubular structure 1900.

FIGS. 21A-21C illustrate an example of actuation of the cartridge 1900to couple the cartridge 1900 with a tubular structure 12. Theanastomotic coupler 10, in the example illustrated in FIGS. 21A-21C, caninclude a fixation device 100, 2100. The fixation device 100, 2100 canbe similar to the fixation device 100 described above for FIGS. 1-18 . Aring 300, 2102 can be provided about the tubular structure 12, externalthe annulus 14. The fixation device 2100 includes a housing 102 and anactuation mechanism 150, for example a pusher rod, a button, a motor,and/or any other suitable mechanism to actuate the cartridge 1900. Thecartridge 1900 can be coupled with the fixation device 2100. A stop 104can be positioned on the housing 102 adjacent to the cartridge 1900. Asshown in FIG. 21B, the stop 104 is operable to abut against the edge ofa tubular structure 12 to ensure accurate positioning of the cartridge1900 within the annulus 14 of the tubular structure 12. As illustratedin FIG. 21B, the cartridge 1900 is inserted into the annulus 14 of thetubular structure 12. In at least one example, the ring 2102 can abutthe stop 104 to accurately position the ring 2102 to be aligned with thecartridge 1900.

While the examples illustrated in FIGS. 21A-25C illustrate the cartridge1900 being disposed within the annulus 14 and the ring 2102 disposedexternal the tubular structure 12, in other examples the cartridge 1900can be disposed external the tubular structure 12 while the ring 2102 isdisposed within the annulus 14.

As shown in FIG. 21B, the actuation mechanism 150 can be actuated, forexample pulled away from the housing 102, to move the sheath 2000 toexpose the fasteners 1902. Other mechanisms to remove the sheath 2000 toexpose the fasteners 1902 can be utilized, for example pulling a string,cutting apart the sheath 2000, or any other suitable mechanism to exposethe fasteners 1902 of the cartridge 1900 after the cartridge 1900 hasbeen disposed within the annulus 104 of the tubular structure 102.

As illustrated in FIG. 21C, the actuation mechanism 150 can be actuated,for example rotated or push a button or any other suitable mechanism, torotate the cartridge 1900 and puncture the tubular structure 12 with thefasteners 1902. The fasteners 1902 are operable to be rotated to engagethe tubular structure 12, as the fasteners 1902 extend at the angle1902A from the body 1901 of the cartridge 1900.

In some examples, the cartridge 1900 can also expand radially to pushthe body 1901 of the cartridge 1900 and subsequently the fasteners 1902against the tubular structure 12. In some examples, the body 1901 of thecartridge 1900 and/or the fasteners 1902 can expand radially byexpansion, rotation, balloon expansion, traction, compression, and/orany other suitable mechanism. By pushing the fasteners 1902 against thetubular structure 12, the fasteners 1902 may puncture the tubularstructure 12. In some examples, the cartridge 1900 and/or the fasteners1902 can be rotated after puncturing the tubular structure 12 to securethe coupling of the cartridge 1900 with the tubular structure 12.

The fasteners 1902 are then secured by and/or in the ring 2102 tomaintain the position and coupling of the cartridge 1900 with thetubular structure 12. Examples of the mechanism to retain the fasteners1902 in the ring 2102 and/or configurations of the cartridge 1900 areillustrated in FIGS. 22A-25C. FIGS. 22A-25C illustrate differentmechanisms of utilizing gaskets 2200 as receiving portions for thefasteners 1902.

FIGS. 22A-22C illustrate an example of a cartridge 1900 that has one rowof fasteners 1902 and rings 300 that secure the fasteners 1902 bycompression between two gaskets 2200. To secure two tubular structures20, 22 to the cartridge 1900, the two tubular structures 20, 22 mayoverlay one another over the fasteners 1902 of the cartridge 1900. Thefasteners 1902 may puncture the two tubular structures 20, 22 to securethe cartridge 1900 against the two tubular structures 20, 22 and alignthe lumen 14 of each of the tubular structures 20, 22 and the lumen 1903of the cartridge 1900. Accordingly, fluid can pass through a tubularstructure 20, through the cartridge 1900, and to the other tubularstructure 22.

As illustrated in FIGS. 22B-22C, the two rings 2102, 2103 can be broughttogether to couple with one another via mating portions 352, 362(similar to FIGS. 1-18 ). Upon coupling of the mating portions 352, 362,gaskets 2200 for each of the rings 2102, 2103 compress against eachother, receiving the fasteners 1902 between the two gaskets 2200. Insome examples, the compression of the gaskets 2200 against the fasteners1902 can sufficiently secure the coupling of the rings 2102, 2103 withthe cartridge 1900. In some examples, after compression of the gaskets2200 against the fasteners 1902, the fasteners 1902, the rings 2102,2103, and/or the gaskets 2200 may be rotated so that the fasteners 1902puncture into the gaskets 2200. In some examples, the fasteners 1902 maybe received by the gaskets 2200 or the ring 2102, 2103. In someexamples, the gaskets 2200 can be made of any biocompatible materialincluding silicone, rubber, and other elastomers, includingthermoplastic and/or bioresorbable elastomers. In some examples, thegaskets 2200 can be made of polyurethane elastomer, polydiene,poly(vinyl) chloride elastomers, and/or any other suitable material.

FIGS. 23A-23C illustrate an example of utilizing two separate cartridges1900 coupled with a corresponding tubular structure 20, 22, and securingthe fasteners 1902 by compression between the two gaskets 2200. Asillustrated in FIGS. 23A-23C, each of the cartridges 1900 can include atleast one row of fasteners 1902. Each of the fasteners 1902 havepunctured the corresponding tubular structures 20, 22. The two tubularstructures 20, 22, each with cartridges 1900 coupled thereto, arebrought together so that the lumens 14 are in fluid communication withone another through the lumens 1903 of the cartridges 1900. Similar toFIGS. 22A-22C, the rings 2102, 2103 are brought together and coupledwith one another via mating portions 352, 362. Upon bringing the rings2102, 2103 together, gaskets 2200 for each of the rings 2102, 2103compress against each other, receiving the fasteners 1902 for the twocartridges 1900 between the two gaskets 2200. In some examples, thecompression of the gaskets 2200 against the fasteners 1902 cansufficiently secure the coupling of the rings 2102, 2103 with thecartridges 1900. In some examples, after compression of the gaskets 2200against the fasteners 1902, the fasteners 1902, the rings 2102, 2103,and/or the gaskets 2200 may be rotated so that the fasteners 1902puncture into the gaskets 2200. In some examples, the fasteners 1902 maybe received by the gaskets 2200 or the ring 2102, 2103.

FIGS. 24A-24C illustrate an example of the fasteners 1902 directlypuncturing into the gasket 2200 of the corresponding ring 300 whilepuncturing through the tubular structure 12. The rings 2102, 2103 arethen brought together and coupled with one another via mating portions352, 362. While FIGS. 24A-24C illustrate an example similar to FIGS.23A-23C where two separate cartridges 1900 are utilized, in someexamples, similar to FIGS. 22A-22C, one cartridge 1900 may be utilized.FIGS. 24A-24C illustrate the mechanism of the fasteners 1902 beingdirectly received in and/or puncturing the corresponding gasket 2200.This mechanism can be utilized in addition to and/or in place ofcompressing the fasteners 1902 with the gaskets 2200.

FIGS. 25A-25C illustrate an example of a cartridge 1900 that includestwo (or more) rows of fasteners 1902 on one body 1901. Accordingly,instead of overlaying the two tubular structures 20, 22 as in FIGS.22A-22C, each tubular structure 20, 22 may couple with a correspondingrow of fasteners 1902. In some examples, even with multiple rows offasteners 1902, the tubular structures 20, 22 may still overlap over oneor more rows of fasteners 1902. The rings 2102, 2103 are broughttogether and coupled with one another via mating portions 352, 362. Uponbringing the rings 2102, 2103 together, gaskets 2200 for each of therings 2102, 2103 compress against each other, receiving the fasteners1902 for the two cartridges 1900 between the two gaskets 2200. In someexamples, the compression of the gaskets 2200 against the fasteners 1902can sufficiently secure the coupling of the rings 2102, 2103 with thecartridges 1900. In some examples, after compression of the gaskets 2200against the fasteners 1902, the fasteners 1902, the rings 2102, 2103,and/or the gaskets 2200 may be rotated so that the fasteners 1902puncture into the gaskets 2200.

FIGS. 26A-27N illustrate examples of an anastomotic coupler 10 which isoperable to couple an end of a tubular structure 12 with an end ofanother tubular structure 12. Elements described in the system of FIGS.26A-27N that have similar or the same name and/or the same referencenumbers as elements in the disclosure for FIGS. 1-25C may have the samefeatures as discussed above. While the discussion below for FIGS.26A-27N may highlight some differences in features, the disclosure forthe system of FIGS. 26A-27N are not limited to those and may alsoinclude any and/or all of the features as discussed above.

FIGS. 26A and 26B illustrate examples of a cartridge 200, 2600 for ananastomotic coupler 10. As illustrated in FIGS. 26A and 26B, thecartridge 2600 can include a body 2601 which is operable to be receivedin a tubular structure 12. The body 2601 can have an outer radialsurface 2602 and an axial surface 2604. As will be shown below, theouter radial surface 2602 can be operable to abut against and besubstantially parallel to a wall 13 of the tubular structure 12. In atleast one example, the outer radial surface 2602 can be substantiallyperpendicular to the radial direction away from the center of thecartridge 2600. In at least one example, the outer radial surface 2602can extend substantially parallel to the longitudinal axis X-X. Theaxial surface 2604 can extend at an angle from the outer radial surface2602. In at least one example, the axial surface 2604 can extendsubstantially perpendicular to the longitudinal axis X-X. In at leastone example, the axial surface 2604 can extend substantially parallel tothe radial direction away from the center of the cartridge 2600. In atleast one example, when the outer radial surface 2602 is abutting thewall 13 of the tubular structure 12, the axial surface 2604 can extendat an angle in relation to the wall 13 of the tubular structure 12.

The body 2601 of the cartridge 2600 can form a body lumen 2606 to permitfluid to flow across the body 2601. When the cartridge 2600 ispositioned within the tubular structure 12, fluid can flow through thelumen 14 of the tubular structure 12 as well as through the body lumen2606 of the cartridge 2600. Accordingly, the cartridge 2600, whenpositioned in the tubular structure 12, does not obstruct the flow ofthe fluid through the tubular structure 12.

One or more fasteners 206, 2620 extend from the axial surface 2604 at anangle from the longitudinal axis X-X. The fasteners 2620 can extend fromthe axial surface 2604 at any suitable angle in relation to thelongitudinal axis X-X. For example, the fasteners 2620 can extend at anangle between 1 degree and 89 degrees in relation to the longitudinalaxis X-X, but other angles may be suitable without deviating from thescope of the disclosure. The fasteners 2620 can be operable to puncturethe wall 13 of the tubular structure 12. As the fasteners 2620 extendfrom the axial surface 2604 at an angle from the longitudinal axis X-X,the fasteners 2620 also extend at an angle in relation to the wall 13 ofthe tubular structure 12 when the cartridge 2600 is positioned in thetubular structure 12. Accordingly, the fasteners 2620 being at an anglein relation to the wall 13 of the tubular structure 12 allow for thefasteners 2620 to puncture through the wall 13 of the tubular structure12, coupling the cartridge 2600 to the tubular structure 12.

As illustrated in FIG. 26A, an end 2622 of the fasteners 2620 can besubstantially linear. As illustrated in FIG. 26B, the end 2622 of thefasteners 2620 can be bent. The ends 2622 of the fasteners 2620 can allbe the same or different. For example, the fasteners 2620 can each havean end 2622 that is linear, curved, bent, and/or hooked. The fasteners2620 can each have an end 2622 that has other shapes and configurationswithout deviating from the scope of the disclosure so long as thefasteners 2620 can puncture the wall 13 of the tubular structure 12.

While FIGS. 26A-27N illustrate a cartridge 2600 with three fasteners2620, one, two, four, or more fasteners 2620 can be provided withoutdeviating from the scope of the disclosure. While FIGS. 26A-27Nillustrate a cartridge 2600 with fasteners 2620 all having the samelengths, in some examples, the lengths of the fasteners 2620 can vary.

FIGS. 27A-27N illustrate the application of the anastomotic coupler 10with the cartridge 200, 2600, for example as illustrated in FIGS.26A-26B.

FIG. 27A illustrates an example of a fixation device 100, 2700 that isoperable to position the cartridge 2600 in the tubular structure 12. Inat least one example, the fixation device 2700 can include a body 102and a stop 104, for example as discussed above. The cartridge 2600 canreceive and/or be coupled with the body 102. As illustrated in FIG. 27A,a sheath 2630 can be provided and operable to receive the one or morefasteners 26 such that the fasteners 2620 are covered until thecartridge 2600 is positioned inside the tubular structure 12. In someexamples, when the fasteners 2620 are received in the sheath 2630, thefasteners 2620 can extend from the axial surface 2604 substantiallyparallel to the longitudinal axis X-X. As such, the fasteners 2620 donot prematurely puncture the wall 13 of the tubular structure 12 beforethe cartridge 2600 is positioned as desired in the tubular structure 12.In some examples, the anastomotic coupler 10 does not include a sheath2630, and the fasteners 2620 do not puncture the wall 13 of the tubularstructure 12 until actuated. For example, the fasteners 2620 can beactuated to puncture the wall 13 of the tubular structure 12 by aninflatable balloon that pushes the fasteners 2620 radially outward, bythe user pushing the wall 13 of the tubular structure 12 against thefasteners 2620, by a pusher rod or ball such as a tapered pusher rod150, by traction, and/or by other suitable mechanisms to radially pushthe fasteners 2620 against the wall 13 of the tubular structure 12.

As illustrated in FIG. 27B, the fixation device 2700 is moved toward thetubular structure 12 to insert the cartridge 2600 into the lumen 14 ofthe tubular structure 12. As illustrated in FIGS. 27C and 27D, thecartridge 2600 is positioned inside the tubular structure 12. In atleast one example, the stop 104 can control how far the fixation device2700 is received in the tubular structure 12 so that the cartridge 2600is positioned in the desired location in the tubular structure 12. Asillustrated in FIG. 27D, when the cartridge 2600 is adequatelypositioned in the tubular structure 12, the fixation device 2700 can beactuated to remove the sheath 2630 to expose the fasteners 2620.

As illustrated in FIG. 27E, the sheath 2630 is fully removed to exposethe fasteners 2620. In at least one example, as illustrated in FIG. 27Ethe body 2601 of the cartridge 2600 can have a diameter 2601Dsubstantially the same as a diameter 14D of the lumen 14 of the tubularstructure 12 so that the outer radial surface 2602 abuts against thewall 13 of the tubular structure 12 to maintain the shape of the tubularstructure 12. Accordingly, fluid can still sufficiently flow through thetubular structure 12 and the cartridge 2600.

As illustrated in FIG. 27F, when the sheath 2630 is removed 2620 touncover the fasteners 2620, the fasteners 2620 can be operable to expandradially outward to be at an angle from the longitudinal axis X-X. Assuch, as illustrated in FIGS. 27F-27L, the fasteners 2620 can puncturethe wall 13 of the tubular structure 12.

After the fixation device 2700 is actuated to remove the sheath 2630and/or actuate the fasteners 2620 to puncture the wall 13 of the tubularstructure 12, the fixation device 2700 can be removed and withdrawn fromthe tubular structure 12, as illustrated in FIGS. 27G, 27H, and 27I.

As illustrated in FIGS. 27J, 27K, and 27L, the fasteners 2620 havepunctured the wall 13 of the tubular structure 12, and the fixationdevice 2700 has been removed. Accordingly, the fasteners 2620 extendthrough the wall 13 of the tubular structure 12 at an angle from thelongitudinal axis X-X.

FIG. 27M illustrates coupling the cartridge 2600 and the tubularstructure 12 to a ring 300. The ring 300 can be operable to receive thetubular structure 12. The ring 300 can include a receiving portion 310operable to receive at least a portion of the fasteners 206, 2620 of thecartridge 200, 2600. In at least one example, as the fasteners 2620 havepunctured the wall 13 of the tubular structure 12 at an angle relativeto the longitudinal axis X-X, the fasteners 2620 can also puncture andbe received in the receiving portion 310 of the ring 300. Accordingly,the tubular structure 12 is coupled with the ring 300 via the fasteners2620 of the cartridge 2600. In some examples, the fasteners 2620 can becoupled with the ring 300 via compression within the receiving component310 of the ring 300 and/or between receiving components 310 of two rings300. Accordingly, the receiving component 310 of the ring 300 receivesat least a portion of the fasteners 2620 to couple the ring 300 with thetubular structure 12.

In at least one example, as illustrated in FIG. 27M, the ring 300 caninclude a mating portion 362 operable to couple with the mating portion352 of a corresponding ring 300 for another tubular structure 12. Forexample, as illustrated in 27N, a first tubular structure 20 can becoupled with a first ring 2750 via a cartridge 2600, and a secondtubular structure 22 can be coupled with a second ring 2751 via acartridge 2600.

In at least one example, the fasteners 2620 of the first cartridge 2600corresponding with the first tubular structure 20 can extend through thereceiving portion 310 of the first ring 2750 and be received in thereceiving portion 310 of the second ring 2751 such that the first ring2750 and the second ring 2751 are coupled to one another. In someexamples, the fasteners 2620 of the second cartridge 2600 correspondingwith the second tubular structure 22 can extend through the receivingportion 310 of the second ring 2751 and be received in the receivingportion 310 of the first ring 2750 such that the first ring 2750 and thesecond ring 2751 are coupled to one another.

In at least one example, the first ring 2750 includes a mating portion362, and the second ring 2751 includes a corresponding mating portion352. The mating portion 352 is operable to couple with the matingportion 362 to couple the first ring 2750 and the second ring 2751 withone another. In some examples, the rings 300 can be coupled with oneanother by, for example, fastening, snapping, clamping, stenting,tacking, pinning, loop and hook, adhesive, and/or other connectingmethod so long as the rings 300 are securely coupled with one another.

As illustrated in FIG. 27N, when the rings 2750, 2751 are coupled withone another, the lumens 14 of the two tubular structures 20, 22 arealigned in fluid communication with one another. In at least oneexample, the rings 2750, 2751 can create a seal to prevent fluidleakage. Accordingly, the anastomotic coupler 10 provides a morereliable, faster, more secure anastomotic coupling device to create asealed, leak-proof, open connection between the ends of the tubularstructures 20, 22 and allow for “stented” unobstructed flow of luminalcontents through the connection/anastomosis (e.g. blood, lymph, fluid,stool contents, gastric contents, etc.). This connection can be strongenough to withstand tension, traction, and high flow pressure, which mayoccur with distal obstruction.

In some examples, a cap 1400 (for example as shown in FIG. 14 ) can beprovided over the two rings 2750, 2751. The cap 1400 can assist inensuring the connection between the rings 2750, 2751, as well asprotecting the rings 2750, 2751 from external damage. In some examples,the cap 1400 can be deformed to snap over the two rings 2750, 2751.

FIG. 28 illustrates a cartridge 200, 2800 for an anastomotic coupler 10.As illustrated in FIG. 28 , the cartridge 2800 can include a body 2801which is operable to be received in a tubular structure 12. The body2801 can have an outer radial surface 2802 and an axial surface 2804. Aswill be shown below, the outer radial surface 2802 can be operable toabut against and be substantially parallel to a wall 13 of the tubularstructure 12. In at least one example, the outer radial surface 2802 canbe substantially perpendicular to the radial direction away from thecenter of the cartridge 2800. In at least one example, the outer radialsurface 2802 can extend substantially parallel to the longitudinal axisX-X. The axial surface 2804 can extend at an angle from the outer radialsurface 2802. In at least one example, the axial surface 2804 can extendsubstantially perpendicular to the longitudinal axis X-X. In at leastone example, the axial surface 2804 can extend substantially parallel tothe radial direction away from the center of the cartridge 2800. In atleast one example, when the outer radial surface 2802 is abutting thewall 13 of the tubular structure 12, the axial surface 2804 can extendat an angle in relation to the wall 13 of the tubular structure 12.

The body 2801 of the cartridge 2800 can form a body lumen 2806 to permitfluid to flow across the body 2801. When the cartridge 2800 ispositioned within the tubular structure 12, fluid can flow through thelumen 14 of the tubular structure 12 as well as through the body lumen2806 of the cartridge 2800. Accordingly, the cartridge 2800, whenpositioned in the tubular structure 12, does not obstruct the flow ofthe fluid through the tubular structure 12.

The cartridge 2800 can also include a support 2840 and one or morecolumns 2830 that extend between the body 2801 (for example the axialsurface 2804) and the support 2840. As illustrated in FIG. 28 , thecartridge 2800 can include three columns 2830. In some examples, thecartridge 2800 can include one, two, or more than three columns withoutdeviating from the scope of the disclosure.

In at least one example, the support 2840 has substantially the sameshape and/or size as the body 2801. The support 2840 can have a supportouter radial surface 2842 and a support axial surface 2844. In at leastone example, the support axial surface 2844 can substantially face theaxial surface 2804. The support outer radial surface 2842 can beoperable to abut against and be substantially parallel to a wall 13 ofthe tubular structure 12. In at least one example, the support outerradial surface 2842 can be substantially perpendicular to the radialdirection away from the center of the cartridge 2800. In at least oneexample, the support outer radial surface 2842 can extend substantiallyparallel to the longitudinal axis X-X. The support axial surface 2844can extend at an angle from the support outer radial surface 2842. In atleast one example, the support axial surface 2844 can extendsubstantially perpendicular to the longitudinal axis X-X. In at leastone example, the support axial surface 2844 can extend substantiallyparallel to the radial direction away from the center of the cartridge2800. In at least one example, when the support outer radial surface2842 is abutting the wall 13 of the tubular structure 12, the supportaxial surface 2844 can extend at an angle in relation to the wall 13 ofthe tubular structure 12.

The support 2840 of the cartridge 2800 can form a support lumen 2846 topermit fluid to flow across the support 2840. The support lumen 2846 canbe in fluid communication with the body lumen 2806 such that fluid canflow across the entire cartridge 2800. When the cartridge 2800 ispositioned within the tubular structure 12, fluid can flow through thelumen 14 of the tubular structure 12 as well as through the body lumen2806 and the support lumen 2846 of the cartridge 2800. Accordingly, thecartridge 2800, when positioned in the tubular structure 12, does notobstruct the flow of the fluid through the tubular structure 12. Thesupport 2840 can provide additional support to the tubular structure 12in addition to the body 2801.

One or more fasteners 206, 2820 extend from the axial surface 2804. Thefasteners 2820 can be operable to puncture the wall 13 of the tubularstructure 12, coupling the cartridge 2600 to the tubular structure 12.As illustrated in FIGS. 28A and 28B, in at least one example, thefasteners 206, 2820 can extend substantially perpendicularly from theaxial surface 2804. In at least one example, the fasteners 206, 2820 canbe shipped, stored, and/or implemented with the fasteners 206, 2820substantially perpendicular to the axial surface 2804 (for example,substantially parallel to the longitudinal axis X-X). When the fasteners206, 2820 are received in the tubular structure 12, the fasteners 206,2820 can be transitioned to extend from the axial surface 2804 at anangle to puncture the walls 13 of the tubular structure 12.

As illustrated in FIG. 28 , an end 2822 of the fasteners 2820 can bebarbed to include a barb. In some examples, the end 2822 of thefasteners 2820 can be barbed to include two barbs extending in oppositedirections. In some examples, the end 2622 of each of the fasteners 2820can be substantially linear. In some examples, the end 2822 of thefasteners 2820 can be bent. The ends 2822 of the fasteners 2820 can allbe the same or different. For example, the fasteners 2820 can each havean end 2822 that is barbed, linear, curved, bent, and/or hooked. Thefasteners 2820 can each have an end 2822 that has other shapes andconfigurations without deviating from the scope of the disclosure solong as the fasteners 2820 can puncture the wall 13 of the tubularstructure 12 and maintain coupling with the wall 13.

While FIG. 28 illustrates a cartridge 2800 with three fasteners 2820,one, two, four, or more fasteners 2820 can be provided without deviatingfrom the scope of the disclosure. While FIG. 28 illustrates a cartridge2800 with fasteners 2820 all having the same lengths, in some examples,the lengths of the fasteners 2820 can vary.

As illustrated in FIG. 28 , the cartridge 2800 can include three columns2830. In some examples, the cartridge 2800 can include one, two, or morethan three columns without deviating from the scope of the disclosure.

FIGS. 29A, 29B, and 29C illustrate the cartridge 206, 2900 with thefasteners 2920 extended at an angle 2920A from the axial surface 2904 ofthe body 2901. The features with reference numbers that correspond withthe reference numbers for FIG. 28 can correlate with the features inFIG. 28 .

As illustrated in FIGS. 29A-C, the cartridge 2900 can include a body2901 which is operable to be received in a tubular structure 12. Thebody 2901 can have an outer radial surface 2902 and an axial surface2904. As will be shown below, the outer radial surface 2902 can beoperable to abut against and be substantially parallel to a wall 13 ofthe tubular structure 12. In at least one example, the outer radialsurface 2902 can be substantially perpendicular to the radial directionaway from the center of the cartridge 2900. In at least one example, theouter radial surface 2902 can extend substantially parallel to thelongitudinal axis X-X. The axial surface 2904 can extend at an anglefrom the outer radial surface 2902. In at least one example, the axialsurface 2904 can extend substantially perpendicular to the longitudinalaxis X-X. In at least one example, the axial surface 2904 can extendsubstantially parallel to the radial direction away from the center ofthe cartridge 2900. In at least one example, when the outer radialsurface 2902 is abutting the wall 13 of the tubular structure 12, theaxial surface 2904 can extend at an angle in relation to the wall 13 ofthe tubular structure 12.

The body 2901 of the cartridge 2900 can form a body lumen 2906 to permitfluid to flow across the body 2901. When the cartridge 2900 ispositioned within the tubular structure 12, fluid can flow through thelumen 14 of the tubular structure 12 as well as through the body lumen2906 of the cartridge 2900. Accordingly, the cartridge 2900, whenpositioned in the tubular structure 12, does not obstruct the flow ofthe fluid through the tubular structure 12.

The cartridge 2900 can also include a support 2940 and one or morecolumns 2930 that extend between the body 2901 (for example the axialsurface 2904) and the support 2940. As illustrated in FIGS. 29A-C, thecartridge 2900 can include three columns 2930. In some examples, thecartridge 2900 can include one, two, or more than three columns withoutdeviating from the scope of the disclosure.

In at least one example, the support 2940 has substantially the sameshape and/or size as the body 2901. The support 2940 can have a supportouter radial surface 2942 and a support axial surface 2944. In at leastone example, the support axial surface 2944 can substantially face theaxial surface 2904. The support outer radial surface 2942 can beoperable to abut against and be substantially parallel to a wall 13 ofthe tubular structure 12. In at least one example, the support outerradial surface 2942 can be substantially perpendicular to the radialdirection away from the center of the cartridge 2900. In at least oneexample, the support outer radial surface 2942 can extend substantiallyparallel to the longitudinal axis X-X. The support axial surface 2944can extend at an angle from the support outer radial surface 2942. In atleast one example, the support axial surface 2944 can extendsubstantially perpendicular to the longitudinal axis X-X. In at leastone example, the support axial surface 2944 can extend substantiallyparallel to the radial direction away from the center of the cartridge2900. In at least one example, when the support outer radial surface2942 is abutting the wall 13 of the tubular structure 12, the supportaxial surface 2944 can extend at an angle in relation to the wall 13 ofthe tubular structure 12.

The support 2940 of the cartridge 2900 can form a support lumen 2946 topermit fluid to flow across the support 2940. The support lumen 2946 canbe in fluid communication with the body lumen 2906 such that fluid canflow across the entire cartridge 2900. When the cartridge 2900 ispositioned within the tubular structure 12, fluid can flow through thelumen 14 of the tubular structure 12 as well as through the body lumen2906 and the support lumen 2946 of the cartridge 2900. Accordingly, thecartridge 2900, when positioned in the tubular structure 12, does notobstruct the flow of the fluid through the tubular structure 12. Thesupport 2940 can provide additional support to the tubular structure 12in addition to the body 2901.

One or more fasteners 206, 2920 extend from the axial surface 2904 at anangle from the longitudinal axis X-X. In at least one example, thecartridge 200 can be deployed in the tubular structure 12 with thefasteners 2920 already deployed. In at least one example, the fasteners206 2920 extending at an angle 2920A can abut against and then puncturethe walls 13 of the tubular structure 12. In some examples, the tubularstructure 12 can be pulled and/or pushed against the fasteners 2920 sothat the fasteners 2920 puncture the walls 13 of the tubular structure12. The fasteners 2920 can extend from the axial surface 2904 at anysuitable angle in relation to the longitudinal axis X-X. For example,the fasteners 2920 can extend at an angle 2920A between 1 degree and 89degrees in relation to the longitudinal axis X-X, but other angles maybe suitable without deviating from the scope of the disclosure. In atleast one example, the fasteners 2920 can extend at an angle 2920Abetween about 30 degrees and about 60 degrees. In some examples, theangle 2920A can be between about 40 degrees and about 50 degrees. Insome examples, the angle 2920A can be between about 45 degrees. As willbe discussed further below, the angle 2920A of the fasteners 2920 canimportantly correspond with the taper of the walls of the rings 300 tocreate a seal, provide the desired tensile strength, and sufficientlycouple the anastomotic coupler 10 with the tubular structure 12. Thefasteners 2920 can be operable to puncture the wall 13 of the tubularstructure 12. As the fasteners 2920 extend from the axial surface 2904at an angle from the longitudinal axis X-X, the fasteners 2920 alsoextend at an angle in relation to the wall 13 of the tubular structure12 when the cartridge 2900 is positioned in the tubular structure 12.Accordingly, the fasteners 2920 being at an angle in relation to thewall 13 of the tubular structure 12 allow for the fasteners 2920 topuncture through the wall 13 of the tubular structure 12, coupling thecartridge 2900 to the tubular structure 12.

As illustrated in FIGS. 29A-C, an end 2922 of the fasteners 2920 can bebarbed to include a barb. In some examples, the end 2922 of thefasteners 2920 can be barbed to include two barbs extending in oppositedirections. In some examples, the end 2622 of each of the fasteners 2920can be substantially linear. In some examples, the end 2922 of thefasteners 2920 can be bent. The ends 2922 of the fasteners 2920 can allbe the same or different. For example, the fasteners 2920 can each havean end 2922 that is barbed, linear, curved, bent, and/or hooked. Thefasteners 2920 can each have an end 2922 that has other shapes andconfigurations without deviating from the scope of the disclosure solong as the fasteners 2920 can puncture the wall 13 of the tubularstructure 12 and maintain coupling with the wall 13.

While FIGS. 29A-C illustrates a cartridge 2900 with three fasteners2920, one, two, four, or more fasteners 2920 can be provided withoutdeviating from the scope of the disclosure. While FIGS. 29A-Cillustrates a cartridge 2900 with fasteners 2920 all having the samelengths, in some examples, the lengths of the fasteners 2920 can vary.

As illustrated in FIGS. 29A-C, the cartridge 2900 can include threecolumns 2930. In some examples, the cartridge 2900 can include one, two,or more than three columns without deviating from the scope of thedisclosure.

FIG. 30 illustrates a cartridge 200, 3000 substantially similar to thecartridge 2900 of FIGS. 29A-29C. The reference numbers for the cartridge3000 can correspond with the reference numbers for the cartridge 2900.The cartridge 3000 can include a beveled surface 3050 for the support3040. In at least one example, the beveled surface 3050 can be oppositethe support axial surface 3044 in relation to the support radial surface3042. The beveled surface 3050 can assist in inserting the cartridge3000 into the tubular structure 12.

FIGS. 31A and 31B illustrate the cartridge 200, 2900 deployed in thetubular structure 12 and coupled with a male ring 300, 3100. FIG. 31Cillustrates the male ring 3100.

The male ring 3100 includes a body 3102 that forms an aperture 3104. Themale ring 310 is operable to receive a tubular structure 12 through theaperture 3104. While the male ring 3100 as illustrated in FIG. 1A has asubstantially circular shape, the male ring 3100 can have any suitableshape such as rectangular, triangular, octagonal, hexagonal, and/oroval. Additionally, the male ring 3100 as illustrated in FIG. 1A is asingular solid piece, in some examples, for ease of application ormanufacturing purposes, the male ring 3100 can include two semi-circularor arc-type pieces that are joined together around the tubular structure12.

The male ring 3100 can include a front end 3120 and a rear end 3122opposite the front end 3120. The front end 3120 can be operable to beinserted into and/or received by a female ring 3200 (as illustrated inFIGS. 32A-33 ). The male ring 3100 can include a projection 3106 thatextends from the body 3102. In at least one example, the projection 3106extends around the entire circumference of the body 312. In at least oneexample, the projection 3106 can have a radius 3106R about 0.1millimeters.

The size of the male ring 3100 and the lumen 3104 of the male ring 3100can vary based on the application and the size of the tubular structure12. For example, the diameter of the lumen 3104 can range from about 0.5millimeters (mm) (for example for lymphatic connections) to about 60millimeters (for example for gastrointestinal connections). Due to therange of diameters for the male ring 3100, and the range of diametersfor the tubular structure 12, the appropriate male ring 3100 can beselected by measuring the internal diameter of the tubular structure 12.This can be accomplished, for example, with an intraluminal measurementguide/device. If there is a significant size mismatch (1 mm or greater)between the tubular structure 12 and the male ring 3100, then a short,cylindrical tube connector with a corresponding male and female end canbe used to allow for gradual transition in size in any direction toaccommodate the size difference. For example, a cylindric tube can beprovided that tapers in size such that one end is 1 mm-2 mmlarger/smaller than the other end, which would enable a connection of a1 mm vessel to a 2.5 mm-3.5 mm vessel during microsurgical procedureswithout problem and vice versa.

The male ring 3100 can include a male receiving portion 3108 formed as aportion of the lumen 3104. In at least one example, the male receivingportion 3108 can be formed adjacent to the front end 3120 of the body3102. The male receiving portion 318 can be in the form of a notch or arecess. The male receiving portion 318 can have a width 3108W betweenabout 0.3 millimeters and about 1.0 millimeters. In some examples, thewidth 3108W can be between about 0.4 millimeters and about 0.7millimeters. In some examples, the width 3108W can be about 0.5millimeters. The lumen 3104, as illustrated in FIGS. 31A-C can havewalls 3110 that taper at an angle such that a diameter of the lumen 3104decreases from a front diameter 3140D at the end of the male receivingportion 3108 near the front end 3120 of the body 3102 to a rear diameter3142D at the rear end 3122 of the body 3102.

The walls 3110 of the lumen 3104 can taper at an angle 3110A betweenabout 2 degrees and about 8 degrees. In some examples, the walls 3110can taper at an angle 3110A between about 3 degrees and about 6 degrees.In some examples, the walls 131 can taper at an angle 3110A betweenabout 4 degrees and about 5 degrees. In some examples, the walls 131 cantaper at an angle 3110A about 4.46 degrees. The taper can create a sealwith the tubular structure 12 and provide tensile strength.

In at least one example, the walls 3110 are operable to compress thefasteners 2920 extending from the tubular structure 12 against theexternal side of the walls 13 of the tubular structure 12. For example,the fasteners 2920 can puncture the walls 13 of the tubular structure 12at the angle 2920A of the fasteners 2920 (for example, about 45degrees). The male ring 3100 can be slid along the tubular structure 12to be positioned over the cartridge 2900 such that the walls 3110 of themale ring 3100 abut against and compress the fasteners 2920. The angle3110A of the walls 3110 of the male ring 3100 corresponding to the angle2920A of the fasteners 2900 can provide desired coupling of thecartridge 2900 and the male ring 3100 with the tubular structure 12 aswell as the desired tensile strength. In at least one example, thefasteners 2920 may not puncture the walls 3110 of the male ring 3100. Insome examples, the fasteners 2920 may puncture the walls 3110 of themale ring 3100.

The annulus 14 of the tubular structure 12 can be aligned and/or influid communication with the annulus 3104 of the male ring 3100 suchthat fluid can flow between the annulus 14 of the tubular structure 12and the annulus 3104 of the male ring 3100.

The male ring 3100 and/or the cartridge 2900 can be made frommechanically suitable materials that are approved, and have sufficientstrength, for use in the human or animal body. For example, thefollowing materials, alone or in any combination, can be used: metals,in particular titanium or stainless steel, including the special alloysused for implants and medical instruments, nitinol, carbon materials,including carbon fiber meshes, soft plastic, for example silicone, hardplastic, for example Teflon, ceramic material, and/or bioresorbablematerial. The male ring 3100 and/or the fastener 20 can be providedentirely or partially with a coating and/or structure that prevents orat least reduces the adherence of blood constituents. Such a coating canbe composed of a material that smooths the surface. In at least oneexample, the coating can also contain anti-thrombotic medicaments (e.g.heparin).

FIGS. 32A and 32B illustrate the cartridge 200, 2900 deployed in thetubular structure 12 and coupled with a female ring 300, 3200.

The female ring 3200 includes a body 3202 that forms an aperture 3204.The female ring 320 is operable to receive a tubular structure 12through the aperture 3204. While the female ring 3200 as illustrated inFIG. 1A has a substantially circular shape, the female ring 3200 canhave any suitable shape such as rectangular, triangular, octagonal,hexagonal, and/or oval. Additionally, the female ring 3200 asillustrated in FIG. 1A is a singular solid piece, in some examples, forease of application or manufacturing purposes, the female ring 3200 caninclude two semi-circular or arc-type pieces that are joined togetheraround the tubular structure 12.

The female ring 3200 can include a front end 3220 and a rear end 3222opposite the front end 3220. The front end 3220 can be operable to bereceive a male ring 3100 (as illustrated in FIG. 33 ).

The size of the female ring 3200 and the lumen 3204 of the female ring3200 can vary based on the application and the size of the tubularstructure 12. For example, the diameter of the lumen 3204 can range fromabout 0.5 millimeters (mm) (for example for lymphatic connections) toabout 60 millimeters (for example for gastrointestinal connections). Dueto the range of diameters for the female ring 3200, and the range ofdiameters for the tubular structure 12, the appropriate female ring 3200can be selected by measuring the internal diameter of the tubularstructure 12. This can be accomplished, for example, with anintraluminal measurement guide/device. If there is a significant sizemismatch (1 mm or greater) between the tubular structure 12 and thefemale ring 3200, then a short, cylindrical tube connector with acorresponding male and female end can be used to allow for gradualtransition in size in any direction to accommodate the size difference.For example, a cylindric tube can be provided that tapers in size suchthat one end is 1 mm-2 mm larger/smaller than the other end, which wouldenable a connection of a 1 mm vessel to a 2.5 mm-3.5 mm vessel duringmicrosurgical procedures without problem and vice versa.

The female ring 3200 can include a female receiving portion 3240 formedas a portion of the lumen 3204. In at least one example, the femalereceiving portion 3240 can be formed adjacent to the front end 3220 ofthe body 3202. The female receiving portion 3240 can be in the form of anotch or a recess. The female receiving portion 3240 can have a lip 3206that extends into the female receiving portion 3240. As illustrated inFIG. 33 , the lip 3206 can correspond with the protrusion 3106 such thatwhen the male ring 3100 is received in the female receiving portion3240, the protrusion 3106 extends into and past the lip 3206. Once theprotrusion 3106 is inserted past the lip 3206, the abutment between theprotrusion 3106 and the lip 3206 couple the male ring 3100 with thefemale ring 3200. Accordingly, the lip 3206 and the protrusion 3106provide a snap fit between the male ring 3100 and the female ring 3200.

The female receiving portion 3240 also includes a recess 3282 that isoperable to receive the front end 3120 of the male ring 3100. Asillustrated in FIG. 33 , an abutment 3208 adjacent to the recess 3282 isoperable to be received in the male receiving portion 3108. With therecess 3282 and the abutment 308 corresponding with the front end 3120and the male receiving portion 3108, the male ring 3100 and the femalering 3200 are aligned and coupled with one another. With the recess 3282and the abutment 3208 corresponding with the front end 3120 and the malereceiving portion 3108, the male ring 3100 and the female ring 3200 areoperable to create a seal such that fluid does not leak out of theanastomotic coupler. The male ring 3100 and the female ring 3200 areoperable to join together with compression to create a seal and preventleakage.

The walls 3210 of the lumen 3204 can taper at an angle 3210A betweenabout 2 degrees and about 8 degrees. In some examples, the walls 3210can taper at an angle 3210A between about 3 degrees and about 6 degrees.In some examples, the walls 132 can taper at an angle 3210A betweenabout 4 degrees and about 5 degrees. In some examples, the walls 132 cantaper at an angle 3210A about 4.46 degrees. The taper can create a sealwith the tubular structure 12 and provide tensile strength.

In at least one example, the walls 3210 are operable to compress thefasteners 2920 extending from the tubular structure 12 against theexternal side of the walls 13 of the tubular structure 12. For example,the fasteners 2920 can puncture the walls 13 of the tubular structure 12at the angle 2920A of the fasteners 2920 (for example, about 45degrees). The female ring 3200 can be slid along the tubular structure12 to be positioned over the cartridge 2900 such that the walls 3210 ofthe female ring 3200 abut against and compress the fasteners 2920. Theangle 3210A of the walls 3210 of the female ring 3200 corresponding tothe angle 2920A of the fasteners 2900 can provide desired coupling ofthe cartridge 2900 and the female ring 3200 with the tubular structure12 as well as the desired tensile strength. In at least one example, thefasteners 2920 may not puncture the walls 3210 of the female ring 3200.In some examples, the fasteners 2920 may puncture the walls 3210 of thefemale ring 3200.

The annulus 14 of the tubular structure 12 can be aligned and/or influid communication with the annulus 3204 of the female ring 3200 suchthat fluid can flow between the annulus 14 of the tubular structure 12and the annulus 3204 of the female ring 3200.

The female ring 3200 and/or the cartridge 2900 can be made frommechanically suitable materials that are approved, and have sufficientstrength, for use in the human or animal body. For example, thefollowing materials, alone or in any combination, can be used: metals,in particular titanium or stainless steel, including the special alloysused for implants and medical instruments, nitinol, carbon materials,including carbon fiber meshes, soft plastic, for example silicone, hardplastic, for example Teflon, ceramic material, and/or bioresorbablematerial. The female ring 3200 and/or the fastener 20 can be providedentirely or partially with a coating and/or structure that prevents orat least reduces the adherence of blood constituents. Such a coating canbe composed of a material that smooths the surface. In at least oneexample, the coating can also contain anti-thrombotic medicaments (e.g.heparin).

As illustrated in FIG. 33 , when the rings 3100, 3200 are coupled withone another, the lumens 14 of the two tubular structures 12 are alignedin fluid communication with one another. In at least one example, therings 3100, 3200 can create a seal to prevent fluid leakage.Accordingly, the anastomotic coupler 10 provides a more reliable,faster, more secure anastomotic coupling device to create a sealed,leak-proof, open connection between the ends of the tubular structures12 and allow for “stented” unobstructed flow of luminal contents throughthe connection/anastomosis (e.g. blood, lymph, fluid, stool contents,gastric contents, etc.). This connection can be strong enough towithstand tension, traction, and high flow pressure, which may occurwith distal obstruction.

The disclosures shown and described above are only examples. Even thoughnumerous properties and advantages of the present technology have beenset forth in the foregoing description, together with details of thestructure and function of the present disclosure, the disclosure isillustrative only, and changes may be made in the detail, especially inmatters of shape, size and arrangement of the parts within theprinciples of the present disclosure to the full extent indicated by thebroad general meaning of the terms used in the attached claims. It willtherefore be appreciated that the examples described above may bemodified within the scope of the appended claims.

1. A cartridge for an anastomotic coupler, the cartridge comprising: aframe including a body, a support, and one or more columns extendingbetween the body and the support, the frame being operable to bereceived in a tubular structure extending along a longitudinal axis, thebody having a body outer radial surface and a body axial surface, thebody axial surface extending at an angle from the body outer radialsurface, the support having a support outer radial surface and a supportaxial surface facing the body axial surface, the body radial surface andthe support radial surface each operable to abut against and besubstantially parallel to a wall of the tubular structure; and one ormore fasteners extending from the body axial surface at an angle fromthe longitudinal axis, the one or more fasteners operable to puncturethe wall of the tubular structure.
 2. The cartridge of claim 1, whereinthe one or more fasteners each have an end that includes at least onebarb.
 3. The cartridge of claim 1, wherein the one or more fastenerseach have an end that is linear, curved, bent, and/or hooked.
 4. Thecartridge of claim 1, wherein the body and the support of the frame eachhave a diameter substantially the same as a diameter of the lumen of thetubular structure so that the body outer radial surface and the supportouter radial surface each abuts against the wall of the tubularstructure to maintain the shape of the tubular structure.
 5. Thecartridge of claim 1, wherein the body and the support each forms alumen to permit fluid to flow across the frame.
 6. The cartridge ofclaim 1, wherein the angle that the one or more fasteners extend fromthe body axial surface is between about 30 degrees and about 60 degrees.7. The cartridge of claim 1, wherein the angle that the one or morefasteners extend from the body axial surface is about 45 degrees.
 8. Ananastomotic coupler comprising: a ring operable to receive a tubularstructure extending along a longitudinal axis; and a cartridge operableto be received in the tubular structure, the cartridge including: aframe including a body, a support, and one or more columns extendingbetween the body and the support, the frame being operable to bereceived in a tubular structure extending along a longitudinal axis, thebody having a body outer radial surface and a body axial surface, thebody axial surface extending at an angle from the body outer radialsurface, the support having a support outer radial surface and a supportaxial surface facing the body axial surface, the body radial surface andthe support radial surface each operable to abut against and besubstantially parallel to a wall of the tubular structure; and one ormore fasteners extending from the body axial surface at an angle fromthe longitudinal axis, the one or more fasteners operable to puncturethe wall of the tubular structure, wherein the ring assists in couplingthe cartridge with the tubular structure.
 9. The anastomotic coupler ofclaim 8, wherein the one or more fasteners each have an end thatincludes at least one barb.
 10. The anastomotic coupler of claim 8,wherein the one or more fasteners each have an end that is linear,curved, bent, and/or hooked.
 11. The anastomotic coupler of claim 8,wherein the body and the support of the frame each have a diametersubstantially the same as a diameter of the lumen of the tubularstructure so that the body outer radial surface and the support outerradial surface each abuts against the wall of the tubular structure tomaintain the shape of the tubular structure.
 12. The anastomotic couplerof claim 8, wherein the body and the support each forms a lumen topermit fluid to flow across the frame.
 13. The anastomotic coupler ofclaim 8, wherein the angle that the one or more fasteners extend fromthe body axial surface is between about 30 degrees and about 60 degrees.14. The anastomotic coupler of claim 8, wherein the angle that the oneor more fasteners extend from the body axial surface is about 45degrees.
 15. The anastomotic coupler of claim 8, wherein the ringincludes a tapered wall operable to abut against the tubular structure,wherein the tapered wall is operable to receive the one or morefasteners to couple the cartridge with the tubular structure.
 16. Theanastomotic coupler of claim 15, wherein the tapered wall abuts againstthe one or more fasteners such that a portion of the fasteners that havepunctured through the tubular structure is compressed between thetapered wall and the wall of the tubular structure.
 17. The anastomoticcoupler of claim 15, wherein the tapered wall is tapered at an anglebetween about 3 degrees and about 6 degrees.
 18. The anastomotic couplerof claim 15, wherein the tapered wall is tapered at an angle of about4.46 degrees.